Orthopedic DisorderNCT05504538
Coracoid Tunnel Widening After ACJ Tight Rope Fixation
A study testing arthroscopic fixation of Acute acromioclavicular joint injury using tight rope and Tight rope in people with Orthopedic Disorder and Orthopedic Devices Associated With Misadventures, run by Cairo University.
Trial summary
studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Orthopedic Disorder, Orthopedic Devices Associated With Misadventures
- What is being tested?
- arthroscopic fixation of Acute acromioclavicular joint injury using tight rope and Tight rope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 15 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with acute (≤ 3 weeks after injury) Rockwood grade III-V ACJ dislocation
Who cannot join
- Patients with associated coracoid fracture, associated rotator cuff tears or glenohumeral arthritis
About this study
Official title: The Correlation Between Coracoid Tunnel Dilatation and Loss of Reduction After Arthroscopic Acromioclavicular Fixation Using Tightrope System, A CT Based Study
studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.
Read the detailed description
Abstract Purpose: To detect coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.
Methods: From July 2016 to Dec 2018, a prospective study was performed at our hospital. Twenty-three patients with acute grade III-V ACJ dislocation were included in the study. Arthroscopic double tight-rope repair of the ACJ was performed. Coracoid tunnel widening was measured by computed tomography (CT) and coraco-clavicular distance was measured on the x-ray immediately post-operative and at 12 months. Constant Shoulder Score, Oxford Shoulder Score, Nottingham Clavicle Score and Visual analogue scale were used as outcome measures at 12 months.
Level of evidence IV Keywords Acute acromioclavicular joint injury . TightRope . Coracoid tunnel dilatation. Loss of reduction.
- Being tested
- arthroscopic fixation of Acute acromioclavicular joint injury using tight rope, Tight rope
- Keywords
- Acute acromioclavicular joint injury ., TightRope ., Coracoid tunnel dilatation., Loss of reduction.
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic fixation of Acute acromioclavicular joint injury using tight ropeProcedure or surgery
arthroscopic fixation of Acute acromioclavicular joint injury using tight rope
Tight ropeDevice
Adjustable button device from Arthrex Naples USA
| Study group | Role | What they receive |
|---|---|---|
| patient with Acute acromioclavicular joint injury | Experimental | patient with Acute acromioclavicular joint injury Receives: Procedure: arthroscopic fixation of Acute acromioclavicular joint injury using tight rope; Device: Tight rope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coracoid tunnel diameter difference between immediate postoperative and final follow up
Radiological outcome using CT scans
Measured: 1 year
Coraco-clavicular distance immediate postoperative and at final follow up
Radiological outcome using X-rays
Measured: 1 year
Secondary outcomes (3)
Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome
Clinical score using a questionnaire
Measured: 1 year
Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome
Clinical score using a questionnaire
Measured: 1 year
Oxford Shoulder score, a questionnaire of 12 questions each scores from 1 to 5. 1 being the fewest symptoms, 5 being the worst. The total score is 60 marks, the higher the score the worse the outcomes
Clinical score using a questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study startJul 2016
- Primary completion15 Jul 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Refaat Waly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504538
- Sponsor's protocol ID
- I-170518
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Coracoid Tunnel Dilatation and Loss of Reduction After Arthroscopic Acromioclavicular Fixation Using Tightrope System, A CT Based Study
- ClinicalTrials.gov ID
- NCT05504538
- Acronym / sponsor ID
- I-170518
- Keywords
- Acute acromioclavicular joint injury ., TightRope ., Coracoid tunnel dilatation., Loss of reduction.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.
Detailed description
Abstract Purpose: To detect coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.
Methods: From July 2016 to Dec 2018, a prospective study was performed at our hospital. Twenty-three patients with acute grade III-V ACJ dislocation were included in the study. Arthroscopic double tight-rope repair of the ACJ was performed. Coracoid tunnel widening was measured by computed tomography (CT) and coraco-clavicular distance was measured on the x-ray immediately post-operative and at 12 months. Constant Shoulder Score, Oxford Shoulder Score, Nottingham Clavicle Score and Visual analogue scale were used as outcome measures at 12 months.
Level of evidence IV Keywords Acute acromioclavicular joint injury . TightRope . Coracoid tunnel dilatation. Loss of reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with Acute acromioclavicular joint injury | Experimental | Procedure: arthroscopic fixation of Acute acromioclavicular joint injury using tight rope, Device: Tight ropepatient with Acute acromioclavicular joint injury |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients with acute (≤ 3 weeks after injury) Rockwood grade III-V ACJ dislocation
Key exclusion criteria (1 listed)
- Patients with associated coracoid fracture, associated rotator cuff tears or glenohumeral arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic fixation of Acute acromioclavicular joint injury using tight ropearthroscopic fixation of Acute acromioclavicular joint injury using tight rope | Procedure or surgery | patient with Acute acromioclavicular joint injury |
| Tight ropeAdjustable button device from Arthrex Naples USA | Device | patient with Acute acromioclavicular joint injury |
Primary outcome
Coracoid tunnel diameter difference between immediate postoperative and final follow up
Time frame: 1 year
Radiological outcome using CT scans
Coraco-clavicular distance immediate postoperative and at final follow up
Time frame: 1 year
Radiological outcome using X-rays
3 secondary outcomes
Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome
Time frame: 1 year
Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome
Time frame: 1 year
Oxford Shoulder score, a questionnaire of 12 questions each scores from 1 to 5. 1 being the fewest symptoms, 5 being the worst. The total score is 60 marks, the higher the score the worse the outcomes
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic fixation of Acute acromioclavicular joint injury using tight rope and Tight rope in people with Orthopedic Disorder and Orthopedic Devices Associated With Misadventures, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coracoid tunnel diameter difference between immediate postoperative and final follow up (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.